IDEAL Care: Identifying Advanced Liver Fibrosis in Primary Care

GP Education will be provided to both arms of the trial. Access to the education module will be provided by the research team at time of the site initiation with provision of hard copy and electronic versions and links available to the GPs within the practice. Education material targeted towards GPs and eligible for RACGP Continuing Professional Development has recently been developed by CIs Leon Adams and Jon Emery. This will be provided to GPs in both arms before the pathway diverges. This will include a virtual or online educational module, a written summary and a clinical pathway with easy to interpret flow-diagrams regarding the identification of at-risk patients and the determination of advanced liver fibrosis. The intervention arm will also be provided with an overview of FHT and the trial intervention. We will evaluate the education module for acceptability and comprehensiveness before trial commencement via review by GP representatives on the steering committee. The outcomes will be used to make any modifications or additions to the education materials. Prior to data collection, both control and intervention practices will have software installed (FHT and GRHANITE) to allow identification of the cohort at risk of chronic liver disease who fit the trial inclusion and exclusion criteria in both arms of the trial. - FHT is a software platform which integrates into current GP practice management software which service greater than 90% of Australian practices. In relation to this trial, FHT will work as the ‘clinical decision support tool’ or ‘pop-up’ within the intervention practices. - GRHANITE software will be installed in both control and intervention practices to enable extraction of de-identified data to the Patron dataset. The FHT CDSS will be installed at consenting general practices for a maximum of 10 months, which will allow up to 4 months for patients to be identified by the CDSS and a further 6 months in order to account for the ascertainment of the primary outcome (newly diagnosed advanced liver fibrosis at 6 months post baseline appointment). FHT analytics will be captured within GRHANITE data surrounding CDSS data usage. Following randomisation, practices assigned to the intervention arm will have the FHT Clinical Decision Support System (CDSS) activated, this will consist of the following: A) Patients fulfilling the at-risk identification criteria will have a FIB-4 score calculated by the FHT platform if the laboratory parameters (consisting of liver enzymes and platelet count) have been collected within the last 3 months. This 3-month time period will be calculated from the day of FHT activation. For any patients with a FIB-4 reported in the previous 3 months, an electronic report will be automatically generated. The reports will be delivered to GP inboxes for review, at which point the GP may determine that a patient should be recalled. It is anticipated that a large number of reports may be generated in some practices. To avoid creating administrative burden for the GP, the reports will be released in a staggered manner (e.g., 30 reports each week on Tuesday). B) For any patients who are either (i) not actively recalled or (ii) do not have a historical FIB-4, GPs will be opportunistically alerted by the CDSS during a consultation from the electronic patient medical record if their patient is at-risk for advanced liver fibrosis and warrant further investigation. During the first consultation, the FHT platform will prompt the GP to commence a two-stage fibrosis detection pathway consisting of; 1) a screening FIB-4 blood test (if no FIB-4 score has been calculated in the last 3 months) and 2) a diagnostic liver elastogram if indicated. Initially, if no FIB-4 score has been calculated in the last 3 months, the GP will be prompted to request a non-fasting, Medicare rebatable, platelet count and liver function test (ALT and AST) to facilitate the calculation of a FIB-4 score. Additional prompts will invite evaluation of current liver disease risk factors using drop-down boxes, reasons for not proceeding with the FIB-4 test if applicable, and a link to a printable patient information sheet regarding liver health, the rationale for the FIB-4 test and liver elastogram. Upon receipt of the laboratory results, a FIB-4 result will be automatically calculated by the FHT platform with a result provided to the GP for review within the electronic medical record (EMR) as part of their normal results workflow. Patients with a FIB-4 <1.3 have a 97% negative predictive value for advanced fibrosis and will not require further follow-up. It is anticipated that 30% of patients tested will have elevated scores (>=1.3) with increased risk of advanced liver fibrosis who will be recalled for review as per normal practice. Age adjusted cut-offs for FIB-4 will not be used due to the increased risk of false negative results. During the 2nd consultation for patients with elevated FIB-4 scores (or the first consultation for those patients with FIB-4 scores already calculated in the last 3 months), the FHT platform will provide the GP with information to explain the result and rationale for a subsequent liver elastography if the screening FIB-4 is high (>=1.3) as well as a list of nearby recommended/preferred providers who offer scans with no out of pocket costs. Liver elastography referrals will be guided by the GP’s usual practice and the cost, wait time and location for the procedure will depend on the individual provider selected. It is anticipated 10-15 scans per month across Western Australia and Victoria will be required which is well within the capacity of elastography providers. During a subsequent consultation (if required), the trial’s education content provided at baseline will provide a care pathway depending on the liver elastography result tailored to the type of elastography and etiology of liver disease using validated cut-offs predictive of advanced liver fibrosis which are also predictive of liver decompensation. Patients with advanced liver fibrosis, invalid or indeterminate elastography values (estimated to be 15-20% of those with a FIB-4 >=1.3) will be recommended for referral to a gastroenterologist/ hepatologist for further evaluation. These referrals will be captured as part of the medical record review during outcome evaluation.